The dispensing and transportation of hazardous fluids, particularly hazardous injectable medicaments, has many complexities. On its simplest level, a needle and syringe combination is typically used to withdraw injectable medicament from a storage container, the needle is capped, and then the syringe is transported to the injection site. The storage container is most often sealed with a pierceable septum formed of an elastomeric material such as latex rubber or the like, captured in an access port. A sharp needle is inserted into the access port piercing the septum to position the distal, open end of the cannula past the septum to make fluid connection with the interior of the access port. Upon withdrawal of the sharp cannula, the elastomeric septum reseals itself, thus maintaining a sterile environment within the storage container. The outer surface of the septum of the injection site is wiped with an antiseptic before each use to prevent septic agents from being drawn into the access port by the piercing movement of the needle.
A similar process may be used to inject the medicament into an intravenous catheter inserted into the vein of a patient, or into a connector in an intravenous fluid line attached to such an intravenous catheter.
However, this simple system particularly fails in the safe handling of hazardous injectable medicaments. Firstly, while it is always dangerous to dispense fluid through sharp needles, because of the dangers of accidental needle stick of medical personnel and the attendant risks of transmitting blood borne diseases, this is particularly true when the injectable medicament is itself a hazardous substance. Such substances include, by way of example only, chemotherapeutic agents and radionuclide agents commonly used for medical imaging purposes. In such cases, accidental needle sticks pose the additional risk of exposure to highly dangerous substances.
Secondly, the traditional needle tipped syringe is not hermetically sealed to contain fluids, at best generally depending on the frictional fit of a syringe barrel and a needle cap to contain liquids. A capped needle is prone to leakage, and syringes containing hazardous agents are apt to leave a trail of contamination behind them during transport. This particularly acute in the transport of radioactive medicaments that are traditionally transported to an intended site of use in a shielded metal transportation vessels, often known as “pigs.” Any leak during transport, even of a minute amount of radioactive material, contaminates the interior surface of the “pig,” which then poses risks to unsuspecting handlers until the “pig” undergoes a painstaking decontamination before it may be reused. Attempts have been made, such as that seen in U.S. Pat. No. 5,180,542 to Brown, to design transport containers that try to contains spills, but a more productive approach would be to prevent contamination in the first place.
Many attempts have been made to increase the safety of administering medicaments through needle and syringe combinations. For example, U.S. Pat. No 6,537,257 to Wien is typical of the approach of trying to guard the sharp needle tip to decrease the chance of accidental needle sticks. Often, these take the form of having retractable guards, as seen in U.S. Pat. No. 6,921,382 to Lee et al. Handling of needle tipped syringes containing hazardous fluid may be minimized with devices such as that seen in U.S. Pat. No. 4,638,809 to Kuperus, where a radionuclide is reconstituted from a lyophilized preparation within the administering syringe, thus halving the number of manipulations that must be made with a typical needle-tipped syringe. However, the risk of needle related accidents, while perhaps attenuated, will remain with all these inventions, and for as long as a needle is part of the apparatus.
Finally, the system of using needles and syringes to dispense, transport, and administer hazardous agents suffers from the dangerous drawback of being “universal” in their access to medical appliances. Since all medical injection needles and elastomeric septum sealed connectors operate in an essentially identical manner, syringes containing hazardous agents may be attached to a large number of injection sites, including patients for whom these hazardous substances are not intended. Furthermore, since essentially all hypodermic needles and syringes in common use interconnect in the same manner and with the same size connectors, commonly know in the art as “Luer lock” connections, there are currently no points in the storage, transport, or administration cycle where hazardous vessels may be isolated from use in everyday intravenous access equipment. In short, there is nothing to prevent a dangerous radionuclide or chemotherapeutic agent from being mistakenly injected into the intravenous tubing of a patient who is not supposed to receive it. The instant invention of a method and apparatus for the handling of hazardous fluids solves these problems utilizing unique series of self-sealing elastomeric interlocking connectors.